Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHOL | CHOLERA (VAXCHORA) | PAXVAX | 1 | Unknown | PO / MO |
Three days after the vaccination with Vaxchora, the patient was started on Augmentin for an ear infection; Three days after the vaccination with Vaxchora, the patient was started on Augmentin for an ear infection; Case reference number US-BN-2024-002819 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-3131) on 26-Nov-2024 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On 22-Nov-2024, the patient took the first dose of Vaxchora vaccine (batch number: unknown) orally, at unknown dose, site of administration, for unknown indication. On an unspecified date, unknown amount of time after vaccination, the patient experienced ear infection. On 25-Nov 2024, three days after the vaccination with Vaxchora, the patient was started with Augmentin for an ear infection (explicitly coded as 'labelled drug-drug interaction medication error '). At the time of the initial report, the outcome of the event of ear infection was unknown. The reporter assessed the event of ear infection as non-serious and causality assessment for the event ear infection was not provided, No further information was provided.; Reporter's Comments: A patient of unspecified age and gender experienced a non-serious event of ear infection an unknown amount of time after the patient took the first dose of Vaxchora vaccine for unknown indication. Reportedly, three days after the vaccination with Vaxchora, the patient was started with Augmentin for an ear infection, which is considered as labelled drug-drug interaction medication error. Ear infection is unlisted and unexpected for Vaxchora per CCDS v1, whilst labelled drug-drug interaction medication error is listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome of the event of ear infection was unknown. The causality for ear infection is considered as not related to Vaxchora, considering the nature of the event. Labelled drug-drug interaction medication error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age and gender experienced a non-serious event of ear infection an unknown amount of time after the patient took the first dose of Vaxchora vaccine for unknown indication. Reportedly, three days after the vaccination with Vaxchora, the patient was started with Augmentin for an ear infection, which is considered as labelled drug-drug interaction medication error. Ear infection is unlisted and unexpected for Vaxchora per CCDS v1 and USPI, whilst labelled drug-drug interaction medication error is listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome of the event of ear infection was unknown. The causality for ear infection is considered as not related to Vaxchora, considering the nature of the event. Labelled drug-drug interaction medication error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE